Oct 29, 2010
Summary:Investigators are recruiting 100 people with relapsing-remitting MS nationwide to participate in a study to determine the safety of adding the experimental oral drug BG00012 to interferon beta (Avonex®, Biogen Idec; Betaseron®, Bayer HealthCare Pharmaceuticals; or Rebif®, EMD Serono) or Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries). The phase 2 study is funded by Biogen Idec.
Everyone enrolled in the study will receive BG00012 therapy, as there is no placebo group in this open-label study.
Rationale: Multiple sclerosis occurs when the immune system mistakenly attacks nerve fiber-insulating myelin and other brain and spinal cord tissues. Although its exact mechanism of action is not known, BG00012, an oral fumarate, is thought to inhibit immune cells and molecules and may be protective against damage to the central nervous system. In a previous phase 2 study involving 257 people with relapsing-remitting MS, treatment with high-dose BG00012 led to a 69% reduction in active inflammation on MRI scans compared with inactive placebo. (Lancet2008;372:1463-72).Phase 3 studies are ongoing, and have completed recruitment.
Eligibility and Details:Participants should be 18 to 55 years old, with a confirmed diagnosis ofrelapsing-remitting MS. Participants must be taking the same dose of Avonex, Betaseron, Rebif, or Copaxone for at least 12 months consecutively at the time of enrollment and must remain on this treatment for the duration of the study. Further enrollment criteria are available from the contact information listed below.
The primary objective of the study is to determine the safety and tolerability of combining BG00012 with existing MS treatments. In secondary assessments, investigators are exploring the effectiveness of the combination by assessing relapses and immune system components, and in a subset of participants, MRI scans.
READ MORE and find test site by clicking here
***********************************************************
“Providing You with ‘MS Views and News’, is what we do“
Keep Informed and up–to–date with information concerning
Multiple Sclerosis when registered at
the MS Views and News website.
****************************************************************
Disclaimer: ‘MS Views and News’ (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
. ****************************************************************
Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews